NCT04964531

Brief Summary

failure of closure of the ductus arteriosus after birth results in a congenital anomaly known as patent ductus arteriosus. The large ductus can induce left side heart remodeling changes which could interfere with the normal cardiac function.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 16, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

July 16, 2021

Status Verified

July 1, 2021

Enrollment Period

1.3 years

First QC Date

June 28, 2021

Last Update Submit

July 6, 2021

Conditions

Congenital Heart DefectPatent Ductus Arteriosus

Outcome Measures

Primary Outcomes (1)

  • change of LV strain after transcatheter closure of the PDA

    Assess the change of left ventricular longitudinal and circumferential strain by speckle tracking echocardiography after PDA closure, and compare this change between the children and adults.

    at base line, within 48 hours after closure of the duct then at three and six months

Study Arms (2)

Adults

group of adults includes all patients aging 19 years or more

Other: speckle tracking echocardiography

children

group of children includes all patients aging less than 19 years

Other: speckle tracking echocardiography

Interventions

speckle tracking echocardiographyOTHER

before and after closure of the PDA , echocardiographic loops of the apical 4, 3 , and 2 chamber will be acquired then processed by special software for measuring the speckle movements in the longitudinal and short axis views

Adultschildren

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

the study population will include all patients diagnosed as having patent ductus arteriosus and this ductus either hemodynamically insignificant but with audible murmur or this duct causes left heart volume overload symptoms

You may qualify if:

  • all patients who are candidate for transcatheter PDA closure.

You may not qualify if:

  • Patients with PDA dependent pulmonary circulation.
  • Patients with small sized PDA which is silent by auscultation.
  • Patients with large sized PDA which is unsuitable for Trans-catheter closure .
  • Patients with PDA and severe irreversible pulmonary hypertension (Eisenmenger's syndrome) (7).
  • Patients with active infection or active infective endarteritis.
  • Patients refusing the study.
  • Patients with DM, HTN and ischemic heart diseases.
  • Patients with associated congenital or acquired cardiac lesions that may interfere with LV mechanics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • Morton SU, Brodsky D. Fetal Physiology and the Transition to Extrauterine Life. Clin Perinatol. 2016 Sep;43(3):395-407. doi: 10.1016/j.clp.2016.04.001. Epub 2016 Jun 11.

    PMID: 27524443BACKGROUND

  • Weir EK, Obreztchikova M, Vargese A, Cabrera JA, Peterson DA, Hong Z. Mechanisms of oxygen sensing: a key to therapy of pulmonary hypertension and patent ductus arteriosus. Br J Pharmacol. 2008 Oct;155(3):300-7. doi: 10.1038/bjp.2008.291. Epub 2008 Jul 21.

    PMID: 18641675BACKGROUND

  • P S, Jose J, George OK. Contemporary outcomes of percutaneous closure of patent ductus arteriosus in adolescents and adults. Indian Heart J. 2018 Mar-Apr;70(2):308-315. doi: 10.1016/j.ihj.2017.08.001. Epub 2017 Aug 9.

    PMID: 29716712BACKGROUND

  • Schneider DJ. The patent ductus arteriosus in term infants, children, and adults. Semin Perinatol. 2012 Apr;36(2):146-53. doi: 10.1053/j.semperi.2011.09.025.

    PMID: 22414886BACKGROUND

  • Mor-Avi V, Lang RM, Badano LP, Belohlavek M, Cardim NM, Derumeaux G, Galderisi M, Marwick T, Nagueh SF, Sengupta PP, Sicari R, Smiseth OA, Smulevitz B, Takeuchi M, Thomas JD, Vannan M, Voigt JU, Zamorano JL. Current and evolving echocardiographic techniques for the quantitative evaluation of cardiac mechanics: ASE/EAE consensus statement on methodology and indications endorsed by the Japanese Society of Echocardiography. Eur J Echocardiogr. 2011 Mar;12(3):167-205. doi: 10.1093/ejechocard/jer021.

    PMID: 21385887BACKGROUND

  • Mondillo S, Galderisi M, Mele D, Cameli M, Lomoriello VS, Zaca V, Ballo P, D'Andrea A, Muraru D, Losi M, Agricola E, D'Errico A, Buralli S, Sciomer S, Nistri S, Badano L; Echocardiography Study Group Of The Italian Society Of Cardiology (Rome, Italy). Speckle-tracking echocardiography: a new technique for assessing myocardial function. J Ultrasound Med. 2011 Jan;30(1):71-83. doi: 10.7863/jum.2011.30.1.71.

    PMID: 21193707BACKGROUND

  • Edvardsen T, Helle-Valle T, Smiseth OA. Systolic dysfunction in heart failure with normal ejection fraction: speckle-tracking echocardiography. Prog Cardiovasc Dis. 2006 Nov-Dec;49(3):207-14. doi: 10.1016/j.pcad.2006.08.008.

    PMID: 17084180BACKGROUND

  • Amoogzar H, Shakiba AM, Derakhshan D, Ajami G, Cheriki S, Borzouee M, Edraki MR, Mehdizadegan N. Evaluation of left ventricular function by tissue Doppler and speckle-derived strain rate echocardiography after percutaneous ductus closure. Pediatr Cardiol. 2015 Jan;36(1):219-25. doi: 10.1007/s00246-014-0989-0. Epub 2014 Aug 9.

    PMID: 25107547BACKGROUND

  • Tilahun B, Tefera E. Transient left ventricular systolic dysfunction following surgical closure of large patent ductus arteriosus among children and adolescents operated at the cardiac centre, Ethiopia. J Cardiothorac Surg. 2013 May 31;8:139. doi: 10.1186/1749-8090-8-139.

    PMID: 23721219BACKGROUND

  • Jeong YH, Yun TJ, Song JM, Park JJ, Seo DM, Koh JK, Lee SW, Kim MJ, Kang DH, Song JK. Left ventricular remodeling and change of systolic function after closure of patent ductus arteriosus in adults: device and surgical closure. Am Heart J. 2007 Sep;154(3):436-40. doi: 10.1016/j.ahj.2007.04.045.

    PMID: 17719286BACKGROUND

  • Zhan Z, Guan L, Pan W, Zhang X, Zhang L, Zhou D, Ge J. Left ventricular size and function after percutaneous closure of patent ductus arteriosus in Chinese adults. Int J Cardiol. 2020 Sep 15;315:24-28. doi: 10.1016/j.ijcard.2020.04.060. Epub 2020 Apr 22.

    PMID: 32333933BACKGROUND

  • Yasuhara J, Kuno T, Kumamoto T, Kojima T, Shimizu H, Yoshiba S, Kobayashi T, Sumitomo N. Comparison of transcatheter patent ductus arteriosus closure between children and adults. Heart Vessels. 2020 Nov;35(11):1605-1613. doi: 10.1007/s00380-020-01639-4. Epub 2020 Jun 3.

    PMID: 32494943BACKGROUND

MeSH Terms

Conditions

Heart Defects, CongenitalDuctus Arteriosus, Patent

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

June 28, 2021

First Posted

July 16, 2021

Study Start

July 1, 2021

Primary Completion

October 1, 2022

Study Completion

February 1, 2023

Last Updated

July 16, 2021

Record last verified: 2021-07